MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LWA; STATION, PIPETTING DILUTING CLINICAL USE

Model Number 337146

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one bd facs¿ lyse wash assistant experienced leakage of uncontained biohazard during use.The following has been provided by the initial reporter: leak checklist from case: 1) was the leak liquid or air? liquid.2) was the leak contained within the instrument? not contained.3) was there spray of liquid under pressure? no.4) what was the fluid that leaked? biohazard.5) did biohazard leak before or after waste line? before waste line.6) was the waste mixed with decontamination/bleach? no.7) was the customer/bd personnel physically in contact with the fluid? no.It was reported by the customer intermittent blood splatter on the carousel rack.(b)(6) 2021 12:34:56 (gmt) customer problem: intermittent blood splatter on the carousel rack.Steps taken with customer/troubleshooting: intermittent blood splatter on the carousel rack.On friday they did get a cell wash probe motion fault error.They would like the engineer as they are worried about cross contamination.They will only run 1 patient sample at a time with fear of blood splatter.Are you using this for clinical diagnostic test? yes.Were erroneous / suspect results flagged before treating a patient? no.Erroneous /suspect results reported? no.Patient(s) treated? no.Software version? unknown.Leak (if yes explain)? no.(b)(6): (b)(6) 2021 12:33:27 (gmt) intermittent blood splatter on the carousel rack.On friday they did get a cell wash probe motion fault error.

Event Description

It has been reported that one bd facs¿ lyse wash assistant experienced leakage of uncontained biohazard during use.The following has been provided by the initial reporter: leak checklist from case 1) was the leak liquid or air? liquid.2) was the leak contained within the instrument? not contained.3) was there spray of liquid under pressure? no.4) what was the fluid that leaked? biohazard.5) did biohazard leak before or after waste line? before waste line.6) was the waste mixed with decontamination/bleach? no.7) was the customer/bd personnel physically in contact with the fluid? no.It was reported by the customer intermittent blood splatter on the carousel rack.(b)(6) 2021 12:34:56 (gmt) customer problem: intermittent blood splatter on the carousel rack.Steps taken with customer/troubleshooting: intermittent blood splatter on the carousel rack.On friday they did get a cell wash probe motion fault error.They would like the engineer as they are worried about cross contamination.They will only run 1 patient sample at a time with fear of blood splatter.Are you using this for clinical diagnostic test? yes.Were erroneous / suspect results flagged before treating a patient? no.Erroneous /suspect results reported? no.Patient(s) treated? no.Software version? unknown.Leak (if yes explain)? no.(b)(6) : (b)(6) 2021 12:33:27 (gmt) intermittent blood splatter on the carousel rack.On friday they did get a cell wash probe motion fault error.

Manufacturer Narrative

H6:.Investigation summary.Scope of issue: the scope of issue is only limited to bd facs lyse wash assistant, part # 337146 and serial # (b)(6).Problem statement: customer reported a complaint regarding a waste leakage not contained within the instrument.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 21sep2020 to date 21sep2021.Complaint trend: there are 9 complaints related to the issue of a waste leakage not contained within the instrument; date range from 21sep2020 to date 21sep2021.Manufacturing device history record (dhr) review: dhr part # 337146 serial # (b)(6), file # (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.Investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis and servicemax, the root cause of the waste leakage not contained within the instrument was due to a worn cell wash assembly.The customer had initially reported that the instrument was spilling patient sample on the carousel rack during sample preparation.The fse (field service engineer) checked the instrument and found that more than 350ul of fluid remained within the sample tubes after processing the patient samples.They also found that the bal seal on the spindle was the source of the leakage and the instrument had a probe motion fault error.Due to all of the issues, the fse replaced the cell wash assembly entirely (pn 34861719).No parts were requested for evaluation because while the cell wash assembly is returnable, it was not required for the investigation.After the repair, the fse cleaned the instrument, checked that the carousel worked, and confirmed that the instrument was functioning as expected.Although the leakage of biohazard has the potential for injury and contamination, no customer or bd personnel came in direct contact and was thus not harmed due to the issue.The leakage was not under pressure and did not significantly increase the risk of exposure.The customer confirmed that though patient samples were used, they were not used in any treatment due to the leakage and didn¿t harm the patient in any way.The safety risk is moderate, s3, as there was no impact to customer health or safety.Service max review: review of related work order #: (b)(4), case # (b)(4).Install date: (b)(6) 2006.Defective part number: 64861719 - assy cell wash mechanism blue repaired.Work order notes: subject / reported: intermittent blood splatter on the carousel rack.Problem description: intermittent blood splatter on the carousel rack.On friday they did get a cell wash probe motion fault error.Work performed: fse checked the instrument and found the volume left in the tube was more than 350ul.Also the bal seal on the spindle had fluid sneaking out.Considering the probe motion fault error, fse replaced the cell wash assembly to address the multiple errors.After part replacement, fse did clean the instrument, tested with tubes on carousel three times, the error was not repeated.Other tests on qualification form passed as well.Cause: defective cell wash assembly.Solution: replacement of the cwa solved the problem.Returned sample evaluation: a return sample was not requested because although the replaced part is returnable, it was not required for the investigation.Risk analysis: risk management file part # 337146ra, rev.02/vers.C, bd facs lyse/wash assistant risk analysis was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes no.Id: (b)(4).Hazard: loss of sample cause: 1.Bad connector.2.Overheated components.3.Insufficient electrical grounding.Harmful effects: delayed results.Risk control: replaced fci connector with improved molex connector.Added cooling fan and vent holes to the reagent door assembly which resulted in 20 degree reduction to door internal temperature.Added ground cable between reagent door and main chassis to complete chassis ground connection to door.Implementation verification: reliability testing in sv lab.Protocol gppd0010-03 rev a.Effectiveness verification: systems level reliability test protocol and report.Probability: 1.Severity: 3.Risk index: 3.Residual risk evaluation: a.New hazards: none.Mitigation(s) sufficient yes no.Root cause: based on the investigation results the root cause of the leakage not contained within the instrument was due to a worn cell wash assembly.Conclusion: based on the investigation results the root cause of the leakage not contained within the instrument was due to a worn cell wash assembly.The fse found that more than 350ul of fluid was left within the sample tube.The fse also found that the bal seal of the spindle was leaking.Due to these issues and the probe motion fault error, the fse replaced the cell wash assembly.After the repair, the fse cleaned the instrument, tested it, and confirmed that it was functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the leakage.The safety risk is moderate, s3, and there was no impact to patient health or safety.

• Brand Name: BD FACS¿ LWA
• Type of Device: STATION, PIPETTING DILUTING CLINICAL USE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12628612
• MDR Text Key: 283420388
• Report Number: 2916837-2021-00396
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 337146
• Device Catalogue Number: 337146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1